80 FR 66906 - Liposome Drug Products: Chemistry, Manufacturing, and Controls; Human Pharmacokinetics and Bioavailability; and Labeling Documentation; Draft Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 210 (October 30, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 210 (October 30, 2015)
| Page Range | 66906-66907 | |
| FR Document | 2015-27744 |
[Federal Register Volume 80, Number 210 (Friday, October 30, 2015)] [Notices] [Pages 66906-66907] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-27744] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2002-D-0093 (Formerly Docket ID 2002D-0337)] Liposome Drug Products: Chemistry, Manufacturing, and Controls; Human Pharmacokinetics and Bioavailability; and Labeling Documentation; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a revised draft guidance for industry entitled ``Liposome Drug Products: Chemistry, Manufacturing, and Controls; Human Pharmacokinetics and Bioavailability; and Labeling Documentation.'' This revised draft guidance document replaces the draft of the same name that published on August 21, 2002. This revised draft guidance provides recommendations to applicants on the chemistry, manufacturing, and controls (CMC); pharmacokinetics and bioavailability; and labeling documentation for liposome drug products submitted in new drug applications (NDAs), abbreviated new drug applications (ANDAs), and biologics license applications (BLAs) reviewed by the Center for Drug Evaluation and Research (CDER). DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by December 29, 2015. ADDRESSES: You may submit comments as follows: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on http://www.regulations.gov. If you want to submit a comment with confidential information that you do not wish to be made available to the public submit the comment as a written/paper submission and in the manner detailed (see ``Written/Paper Submissions'' and ``Instructions''). Written/Paper Submissions Submit written/paper submissions as follows: Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ``Instructions.'' Instructions: All submissions received must include the Docket No. FDA-2002-D-0093 (formerly docket ID 2002D-0337) for ``Liposome Drug Products: Chemistry, Manufacturing, and Controls; Human Pharmacokinetics and Bioavailability; and Labeling Documentation.'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Confidential Submissions--To submit a comment with confidential information that you do not wish to be made publicly available submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on http://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ``confidential.'' Any information marked as ``confidential'' will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ``Search'' box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one self-addressed adhesive [[Page 66907]] label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. FOR FURTHER INFORMATION CONTACT: Richard T. Lostritto, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 4148, Silver Spring, MD 20993-0002, 301- 796-1697. SUPPLEMENTARY INFORMATION: I. Background The FDA is announcing the availability of a revised draft guidance for industry entitled ``Liposome Drug Products: Chemistry, Manufacturing, and Controls; Human Pharmacokinetics and Bioavailability; and Labeling Documentation.'' This revised draft guidance provides recommendations to applicants on the CMC, human pharmacokinetics and bioavailability, and labeling documentation for liposome drug products submitted in NDAs, ANDAs, and BLAs reviewed by CDER. This revision adds BLAs and ANDAs. It also updates the discussions on liposome technology. In the Federal Register of August 21, 2002 (67 FR 54220), FDA announced the availability of a draft version of this guidance. FDA received comments in response to the draft guidance, and this revised guidance reflects FDA's careful consideration of these comments. Most of the changes to the revised draft guidance were made to clarify statements in the 2002 draft guidance. In addition, FDA decided to publish a revised draft guidance because of changes in technology since the draft was first published in 2002, the addition of BLAs reviewed by CDER as a result of a CDER and Center for Biologics Evaluation and Research reorganization in 2003, and the addition of ANDAs. The revised draft guidance does not provide recommendations on clinical efficacy and safety studies, nonclinical pharmacology and/or toxicology studies, liposome formulations of vaccine adjuvants or biologics, or drug-lipid complexes. This revised draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). This revised draft guidance, when finalized, will represent the Agency's current thinking on liposome drug products. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. II. The Paperwork Reduction Act of 1995 This revised draft guidance refers to previously approved collections of information that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR part 314 have been approved under OMB control number 0910-0001. III. Electronic Access Persons with access to the Internet may obtain the revised draft guidance at either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov. Dated: October 26, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-27744 Filed 10-29-15; 8:45 am] BILLING CODE 4164-01-P
![66906 Federal Register / Vol. 80, No. 210 / Friday, October 30, 2015 / Notices
Estimated Total Annual Burden liposome drug products submitted in 2002–D–0093 (formerly docket ID
Hours: 275. new drug applications (NDAs), 2002D–0337) for ‘‘Liposome Drug
Additional Information: Copies of the abbreviated new drug applications Products: Chemistry, Manufacturing,
proposed collection may be obtained by (ANDAs), and biologics license and Controls; Human Pharmacokinetics
writing to the Administration for applications (BLAs) reviewed by the and Bioavailability; and Labeling
Children and Families, Office of Center for Drug Evaluation and Research Documentation.’’ Received comments
Planning, Research and Evaluation, 370 (CDER). will be placed in the docket and, except
L’Enfant Promenade SW., Washington, DATES: Although you can comment on for those submitted as ‘‘Confidential
DC 20447, Attn: ACF Reports Clearance any guidance at any time (see 21 CFR Submissions,’’ publicly viewable at
Officer. All requests should be 10.115(g)(5)), to ensure that the Agency http://www.regulations.gov or at the
identified by the title of the information considers your comment on this draft Division of Dockets Management
collection. Email address: guidance before it begins work on the between 9 a.m. and 4 p.m., Monday
infocollection@acf.hhs.gov. final version of the guidance, submit through Friday.
OMB Comment: OMB is required to either electronic or written comments • Confidential Submissions—To
make a decision concerning the on the draft guidance by December 29, submit a comment with confidential
collection of information between 30 2015. information that you do not wish to be
and 60 days after publication of this ADDRESSES: You may submit comments made publicly available submit your
document in the Federal Register. as follows: comments only as a written/paper
Therefore, a comment is best assured of submission. You should submit two
having its full effect if OMB receives it Electronic Submissions copies total. One copy will include the
within 30 days of publication. Written Submit electronic comments in the information you claim to be confidential
comments and recommendations for the following way: with a heading or cover note that states
proposed information collection should • Federal eRulemaking Portal: http:// ‘‘THIS DOCUMENT CONTAINS
be sent directly to the following: Office www.regulations.gov. Follow the CONFIDENTIAL INFORMATION.’’ The
of Management and Budget, Paperwork instructions for submitting comments. Agency will review this copy, including
Reduction Project, Email: OIRA_ Comments submitted electronically, the claimed confidential information, in
SUBMISSION@OMB.EOP.GOV, Attn: including attachments, to http:// its consideration of comments. The
Desk Officer for the Administration for www.regulations.gov will be posted to second copy, which will have the
Children and Families. the docket unchanged. Because your claimed confidential information
comment will be made public, you are redacted/blacked out, will be available
Robert Sargis, solely responsible for ensuring that your for public viewing and posted on http://
Reports Clearance Officer. comment does not include any www.regulations.gov. Submit both
[FR Doc. 2015–27666 Filed 10–29–15; 8:45 am] confidential information that you or a copies to the Division of Dockets
BILLING CODE 4184–01–P third party may not wish to be posted, Management. If you do not wish your
such as medical information, your or name and contact information to be
anyone else’s Social Security number, or made publicly available, you can
DEPARTMENT OF HEALTH AND confidential business information, such provide this information on the cover
HUMAN SERVICES as a manufacturing process. Please note sheet and not in the body of your
that if you include your name, contact comments and you must identify this
Food and Drug Administration information, or other information that information as ‘‘confidential.’’ Any
[Docket No. FDA–2002–D–0093 (Formerly identifies you in the body of your information marked as ‘‘confidential’’
Docket ID 2002D–0337)] comments, that information will be will not be disclosed except in
posted on http://www.regulations.gov. accordance with 21 CFR 10.20 and other
Liposome Drug Products: Chemistry, • If you want to submit a comment applicable disclosure law. For more
Manufacturing, and Controls; Human with confidential information that you information about FDA’s posting of
Pharmacokinetics and Bioavailability; do not wish to be made available to the comments to public dockets, see 80 FR
and Labeling Documentation; Draft public submit the comment as a written/ 56469, September 18, 2015, or access
Guidance for Industry; Availability paper submission and in the manner the information at: http://www.fda.gov/
detailed (see ‘‘Written/Paper regulatoryinformation/dockets/
AGENCY: Food and Drug Administration, Submissions’’ and ‘‘Instructions’’). default.htm.
HHS. Docket: For access to the docket to
ACTION: Notice of availability. Written/Paper Submissions read background documents or the
Submit written/paper submissions as electronic and written/paper comments
SUMMARY: The Food and Drug follows: received, go to http://
Administration (FDA) is announcing the • Mail/Hand delivery/Courier (for www.regulations.gov and insert the
availability of a revised draft guidance written/paper submissions): Division of docket number, found in brackets in the
for industry entitled ‘‘Liposome Drug Dockets Management (HFA–305), Food heading of this document, into the
Products: Chemistry, Manufacturing, and Drug Administration, 5630 Fishers ‘‘Search’’ box and follow the prompts
and Controls; Human Pharmacokinetics Lane, Rm. 1061, Rockville, MD 20852. and/or go to the Division of Dockets
and Bioavailability; and Labeling • For written/paper comments Management, 5630 Fishers Lane, Rm.
Documentation.’’ This revised draft submitted to the Division of Dockets 1061, Rockville, MD 20852.
guidance document replaces the draft of Management, FDA will post your Submit written requests for single
tkelley on DSK3SPTVN1PROD with NOTICES
the same name that published on comment, as well as any attachments, copies of the draft guidance to the
August 21, 2002. This revised draft except for information submitted, Division of Drug Information, Center for
guidance provides recommendations to marked and identified, as confidential, Drug Evaluation and Research, Food
applicants on the chemistry, if submitted as detailed in and Drug Administration, 10001 New
manufacturing, and controls (CMC); ‘‘Instructions.’’ Hampshire Ave., Hillandale Building,
pharmacokinetics and bioavailability; Instructions: All submissions received 4th Floor, Silver Spring, MD 20993–
and labeling documentation for must include the Docket No. FDA– 0002. Send one self-addressed adhesive
VerDate Sep<11>2014 17:37 Oct 29, 2015 Jkt 238001 PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 E:\FR\FM\30OCN1.SGM 30OCN1](https://thefederalregister.org/doc/80_FR_67116/page/1.svg)
![Federal Register / Vol. 80, No. 210 / Friday, October 30, 2015 / Notices 66907
label to assist that office in processing II. The Paperwork Reduction Act of Electronic Submissions
your requests. See the SUPPLEMENTARY 1995 Submit electronic comments in the
INFORMATION section for electronic
This revised draft guidance refers to following way:
access to the draft guidance document. previously approved collections of • Federal eRulemaking Portal: http://
FOR FURTHER INFORMATION CONTACT: information that are subject to review by www.regulations.gov. Follow the
Richard T. Lostritto, Center for Drug the Office of Management and Budget instructions for submitting comments.
Evaluation and Research, Food and (OMB) under the Paperwork Reduction Comments submitted electronically,
Drug Administration, 10903 New Act of 1995 (44 U.S.C. 3501–3520). The including attachments, to http://
Hampshire Ave., Bldg. 51, Rm. 4148, collections of information in 21 CFR www.regulations.gov will be posted to
Silver Spring, MD 20993–0002, 301– part 314 have been approved under the docket unchanged. Because your
796–1697. OMB control number 0910–0001. comment will be made public, you are
SUPPLEMENTARY INFORMATION: solely responsible for ensuring that your
III. Electronic Access
comment does not include any
I. Background Persons with access to the Internet confidential information that you or a
may obtain the revised draft guidance at third party may not wish to be posted,
The FDA is announcing the
either http://www.fda.gov/Drugs/ such as medical information, your or
availability of a revised draft guidance
GuidanceComplianceRegulatory anyone else’s Social Security number, or
for industry entitled ‘‘Liposome Drug
Information/Guidances/default.htm or confidential business information, such
Products: Chemistry, Manufacturing,
http://www.regulations.gov. as a manufacturing process. Please note
and Controls; Human Pharmacokinetics
and Bioavailability; and Labeling Dated: October 26, 2015. that if you include your name, contact
Documentation.’’ This revised draft Leslie Kux, information, or other information that
guidance provides recommendations to Associate Commissioner for Policy.
identifies you in the body of your
applicants on the CMC, human comments, that information will be
[FR Doc. 2015–27744 Filed 10–29–15; 8:45 am]
pharmacokinetics and bioavailability, posted on http://www.regulations.gov.
and labeling documentation for
BILLING CODE 4164–01–P
• If you want to submit a comment
liposome drug products submitted in with confidential information that you
NDAs, ANDAs, and BLAs reviewed by do not wish to be made available to the
DEPARTMENT OF HEALTH AND
CDER. This revision adds BLAs and public, submit the comment as a
HUMAN SERVICES
ANDAs. It also updates the discussions written/paper submission and in the
on liposome technology. Food and Drug Administration manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
In the Federal Register of August 21, [Docket No. FDA–2010–D–0503]
2002 (67 FR 54220), FDA announced the Written/Paper Submissions
availability of a draft version of this Investigational New Drug Submit written/paper submissions as
guidance. FDA received comments in Applications—Determining Whether follows:
response to the draft guidance, and this Human Research Studies Can Be • Mail/Hand delivery/Courier (for
revised guidance reflects FDA’s careful Conducted Without an Investigational written/paper submissions): Division of
consideration of these comments. Most New Drug Application; Guidance for Dockets Management (HFA–305), Food
of the changes to the revised draft Clinical Investigators, Sponsors, and and Drug Administration, 5630 Fishers
guidance were made to clarify Institutional Review Boards; Partial Lane, Rm. 1061, Rockville, MD 20852.
statements in the 2002 draft guidance. Stay and Republication of Guidance • For written/paper comments
In addition, FDA decided to publish a submitted to the Division of Dockets
revised draft guidance because of AGENCY: Food and Drug Administration,
Management, FDA will post your
changes in technology since the draft HHS.
comment, as well as any attachments,
was first published in 2002, the addition ACTION: Notice of administrative stay of except for information submitted,
of BLAs reviewed by CDER as a result action. marked and identified, as confidential,
of a CDER and Center for Biologics if submitted as detailed in
Evaluation and Research reorganization SUMMARY: The Food and Drug
Administration (FDA or we) is ‘‘Instructions.’’
in 2003, and the addition of ANDAs. Instructions: All submissions received
The revised draft guidance does not announcing a stay of portions of the
final guidance for clinical investigators, must include the Docket No. FDA–
provide recommendations on clinical 2010–D–0503 for ‘‘Investigational New
efficacy and safety studies, nonclinical sponsors, and institutional review
boards (IRBs) entitled ‘‘Investigational Drug Applications—Determining
pharmacology and/or toxicology Whether Human Research Studies Can
studies, liposome formulations of New Drug Applications—Determining
Whether Human Research Studies Can Be Conducted Without an
vaccine adjuvants or biologics, or drug- Investigational New Drug Application;
lipid complexes. Be Conducted Without an IND.’’ We are
republishing the guidance with the Guidance for Clinical Investigators,
This revised draft guidance is being portions that are being stayed clearly Sponsors, and Institutional Review
issued consistent with FDA’s good identified so readers can distinguish Boards; Partial Stay and Republication
guidance practices regulation (21 CFR parts of the guidance that remain in of Guidance.’’ Received comments will
10.115). This revised draft guidance, effect from parts that are subject to this be placed in the docket and, except for
when finalized, will represent the stay. those submitted as ‘‘Confidential
tkelley on DSK3SPTVN1PROD with NOTICES
Agency’s current thinking on liposome Submissions,’’ publicly viewable at
DATES: This stay is effective October 30,
drug products. It does not establish any http://www.regulations.gov or at the
rights for any person and is not binding 2015 Submit either electronic or written Division of Dockets Management
on FDA or the public. You can use an comments on FDA guidances at any between 9 a.m. and 4 p.m., Monday
alternative approach if it satisfies the time. through Friday.
requirements of the applicable statutes ADDRESSES: You may submit comments • Confidential Submissions—To
and regulations. as follows: submit a comment with confidential
VerDate Sep<11>2014 17:37 Oct 29, 2015 Jkt 238001 PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 E:\FR\FM\30OCN1.SGM 30OCN1](https://thefederalregister.org/doc/80_FR_67116/page/2.svg)
Document Created: 2015-12-14 15:29:02
Document Modified: 2015-12-14 15:29:02
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of availability. | |
| Dates | Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by December 29, 2015. | |
| Contact | Richard T. Lostritto, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 4148, Silver Spring, MD 20993-0002, 301- 796-1697. | |
| FR Citation | 80 FR 66906 |
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